i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
NCT ID: NCT06805006
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
100 participants
OBSERVATIONAL
2025-01-01
2025-10-31
Brief Summary
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Detailed Description
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The aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-Stitch instrument in bilateral sacrospinous ligament fixation (SSLF) without the use of a surgical mesh.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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SSLF
Bilateral sacrospinous ligament fixation with i-Stitch device
Eligibility Criteria
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Inclusion Criteria
* SSLF with usage of i-Stitch device (\& i-Stitch Loading Units)
* Concomitant procedures are allowed
* Women minimum 18 years old
* Written informed consent for surgery
Exclusion Criteria
* allergies to the materials used
* benign or malignant changes
* anticoagulation disorders
* autoimmune connective tissue disorders
* any uterus pathologies
18 Years
FEMALE
No
Sponsors
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A.M.I. Agency for Medical Innovations GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Ursula Peschers, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
ISAR Klinikum Munich
Locations
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Isar Kliniken GmbH
Munich, Bavaria, Germany
Countries
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Other Identifiers
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PMCF-03-011
Identifier Type: -
Identifier Source: org_study_id
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